Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byJohn Weroha, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well Avatar-directed chemotherapy works in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that does not respond to platinum anti-cancer drugs. Drugs used in chemotherapy, such as paclitaxel, gemcitabine hydrochloride, pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Using an Avatar, a living tumor sample with similar genetic characteristics to the original tumor, may help determine which chemotherapy is most effective.

Research Team

John Weroha, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Successful Avatar engraftment with successful expansion and treatment outcome of Avatar therapy

Willing to return to enrolling institution for follow-up or have a local physician willing to submit response and outcome data; Note: any and all therapy, potentially in its entirety, may be conducted outside of the Mayo Clinic

Willing to agree that the local medical oncologist may be informed that patient has agreed to participate in the study

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Exclusion Criteria

Uncontrolled intercurrent illness judged by the treating investigator to preclude treatment with chemotherapy

Prior treatment with Doxil, topotecan, Gemzar or Taxol chemotherapy for platinum-resistant cancer; Note: Allowed prior therapy with Doxil or Gemzar if given for platinum sensitive disease in combination with a platinum drug AND the Avatar data indicates a drug other than Doxil or Gemzar would be effective; Note: Allowed prior therapies for patients following confirmation of platinum-resistant cancer include: Therapeutic antibodies, such as bevacizumab; Small molecule kinase inhibitors, such as pazopanib; Vaccines and immunotherapy All of these exceptions should be confirmed with the Principal Investigator (PI) prior to registration

You are pregnant.

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Treatment Details

Interventions

Bevacizumab (Monoclonal Antibodies)
Gemcitabine Hydrochloride (Anti-metabolites)
Paclitaxel (Anti-tumor antibiotic)
Pegylated Liposomal Doxorubicin Hydrochloride (Anti-tumor antibiotic)
Topotecan Hydrochloride (Anti-tumor antibiotic)

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Arm D (Avatar-directed topotecan hydrochloride)Experimental Treatment2 Interventions

Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (Avatar-directed liposomal doxorubicin)Experimental Treatment2 Interventions

Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm B (Avatar-directed gemcitabine hydrochloride)Experimental Treatment1 Intervention

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A (Avatar-directed paclitaxel)Experimental Treatment2 Interventions

Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Bevacizumab is already approved in Japan, Canada for the following indications: